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Pharmaceutical Process Development Manager
3 weeks ago
- The incumbent will oversee the design and optimization of manufacturing processes with technical improvements for regulated markets (US, Canada, EU) within specified timelines.
- Evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) to define design space, control strategy, critical/key parameters, and identify process risks.
- Screen manufacturing sites based on formulation and process complexity/feasibility.
- Lead technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches.
- Define procedures for seamless product transfers between development and manufacturing (in-house and external), ensuring robust scale-up, accurate filings, and successful launches.
- Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure robust performance and timely supply.
- Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
- Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
- Expertise in formulation development of various dosage forms with strong knowledge of process optimization.
- Hands-on experience in technology transfer and scale-up.
- Strong understanding of regulatory guidelines such as USFDA, EMA, WHO.
- Excellent documentation, communication, and analytical skills.
- Ability to work in a fast-paced, dynamic environment.
- Project management and cross-functional coordination.
The ideal candidate will have a passion for driving process improvement and quality excellence.
A collaborative and flexible team player who is able to effectively communicate across multiple functions.
